Jacobi Medical Center

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 51759 Based on medical record (MR) review, document review, and interview, the facility failed to identify gaps in documentation and monitoring of blood administration in one of two incidents reviewed (Patient #11). Findings: Review of the Policy and Procedure (P&P) ... “Occurrence And Hospital Incident Reporting (Patient Safety Events) / Inclusive Of Reporting Under The Safe Medical Devices Act,” (Revised 03/2022), revealed, “Purpose: To ensure (1) that all reportable occurrences are properly documented, monitored and investigated in a timely and thorough manner; and (2) that corrective actions are taken to prevent avoidable and unwanted occurrences that may adversely affect the care and safety of patients...” Document review of incident and occurrence reports revealed that on 02/02/2026, Patient #11 received a blood transfusion with the incorrect blood product. MR review of Patient #11 revealed that in addition to receiving the incorrect blood product, there was no dual nursing sign off for administration of blood products and documentation of vital signs was incomplete. Document review of corrective actions revealed the primary RN for Patient #11 received counseling on correct blood product administration but did not receive counseling on dual nursing sign off for blood administration or vital sign monitoring during blood administration. During interview with Staff G (Administration) on 03/16/2026 at 3:00 PM they acknowledged that the lack of dual sign-off and incomplete vital signs were not identified during their incident investigation, and no specific corrective actions were implemented for these issues.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 51759 Based on medical record (MR) review, document review, and interview, nursing staff failed to complete dual sign-off on blood products and monitor complete vital signs during blood administration in one of two blood administrations reviewed (Patient #11). Findings: Review of the Policy and Procedure (P&P), “Blood Transfusion,” (Revised 03/2024), revealed, “prior to blood transfusion, blood/blood components must be verified by two licensed people (RN/RN, RN/LPN, RN/MD, RN/NP, RN/CNM, RN/CRNA, CRNA/MD, CRMA/DO, and RN/PA), one of whom must be an RN are to sign the transfusion unit tag with name, time and date of transfusion”. Additionally, temperature, pulse, respiration, and blood pressure are taken and documented for all blood/blood components/factor concentrates/factor derivatives. Vital signs must be taken and documented prior to the start of administration of blood, 15 minutes after the start of the transfusion and upon completion of the transfusion. MR review of Patient #11 revealed they presented to the Emergency Department (ED) on 02/02/2026 at 08:04 AM with a chief complaint of fall with head laceration. At 09:34 AM, the registered nurse (RN) documented administration of blood products. The signature line for dual sign off on blood products was blank. Vital signs were taken prior to initiating the blood transfusion. However, the vital signs taken during the transfusion at 09:39 AM and 09:47 AM did not include the patient’s temperature. During interview with Staff G (Administration) on 03/16/2026 at 3:00 PM they acknowledged that dual nursing sign-off should have been performed for the administration of blood products for Patient #11. They also acknowledged that vital signs were incomplete during blood administration.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 16362 48940 . Based on medical record review, document review, and interview, in two (2) of twenty-one (21) medical records reviewed, the facility failed to (A) Ensure mortality cases were reviewed thoroughly to identify opportunities for improvement and (B) Ensure corrective actions aimed at preventing elopement were provided hospital-wide. Findings: See Tag A-0283 .”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 16362 48940 . Based on medical record review, document review, and interview, in two (2) of twenty-one (21) medical records reviewed, the facility failed to identify and analyze opportunities for improvement. Specifically, (A) the facility failed to conduct a complete mortality review for Patient #1 and (B) ensure corrective actions aimed at preventing elopements were provided hospital-wide (Patient #3). Findings: (A) Per the facility organization Quality Improvement Plan for 2023 - 2024, the objectives according to Medical Executives Committee Bylaws, “QAPI is to: a. Establish and maintain an ongoing, systemic, and proactive organization-wide process to measure, assess, and improve patient care and safety ... b. Promote the involvement of care providers in defining quality, establish standards, and develop mechanism to monitor, evaluate, and improve processes and patient outcomes. c. Facilitate an interdisciplinary, collaborative approach to improving the quality of care, patient safety, and utilization of resources through the designation of continuous performance improvement and patient safety initiatives.” The Quality Assurance/Performance Improvement Committee is to “Promote the involvement of care providers in defining quality, established standards, and develop mechanism to monitor, evaluate and improve processes and patient outcomes.” Identify “Patterns and trends in performance will be closely analyzed by the department chairs and quality partners for causality and opportunities for improvement.” A review of the mortality report [document was not dated] of patient #1 revealed a summary of the patient’s four (4) day hospital course. The patient #1 was admitted for the removal of clots from their vascular access used for hemodialysis (a treatment that filters waste and fluid from bloodstream when kidneys no longer function) treatment. The patient expired less than forty-eight (48) hours after the procedure. The final diagnoses included accident due to a mechanical fall without injuries, aspiration pneumonia, Pulseless Electrical Activity (A condition where the heart stopped), cardiogenic shock (Dysfunction of the heart causing inadequate blood flow to the body’s organs), and metabolic acidosis (The buildup of acid in the body). Per an interview on 11/12/24 at 1:55 PM with Staff N (Cardiologist, Attending), they stated the patient had multiple comorbidities when they were admitted to the facility. After the patient underwent a left upper extremity AV Fistula thrombectomy (The removal of clots from a vascular access used for hemodialysis treatment), the patient did not recover and expired. The family did not want an autopsy performed. Staff N reported that the standard of care was met in this case. There was no documentation found that indicated the facility reviewed the quality of care provided to the patient, and no measures were proposed for quality improvement. During an interview with Staff V (Associate Director of Risk Management) and Staff U (Director of Risk Management) on 11/13/2024 at 11:05 AM, Staff V stated that “we conducted a quick review of mortality because the patient was not considered a candidate for a complete mortality review.” Staff V acknowledged that the mortality review was limited to a summary of the patient’s hospital course and did not include an evaluation/analysis of the care provided at the facility. (B) Review of an incident titled “Elopement on 5A Telemetry Unit” dated 10/25/24 indicated that Patient #3 eloped from an inpatient unit while on one (1) to one (1) observation by a Patient Care Associate. The Assistant Director of Nursing (ADN) performed an investigation immediately following the incident and implemented corrective actions that included reeducation of staff to the facility’s observation policy. A review of the 5A Monthly Meeting Minutes dated 10/29/24 indicated that 22 of 53 of the unit’s employees were re-educated to the policy titled “Patient Observation (Non-Behavioral Health Care Units),” last revised 05/2024. There was no documented evidence that all hospital staff involved in the delivery of one (1) to one (1) observation received reeducation. During an interview on 11/13/24 at 10:30 AM, Staff W (Chief Nursing Officer) acknowledged that hospital-wide reeducation was not implemented.”